ICH Draft Quality Risk Management Guidance

FDA has published a draft International Council for Harmonization (ICH) guidance, Quality Risk Management Q9 (R1), to provide a systematic approach to quality risk management for better, more informed, and timely decisions. The ICH says the document “serves as a foundation or resource document that is independent of, yet supports, other ICH quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment.”

The draft says it specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.

ICH says the guidance is not intended to create any new expectations beyond the current regulatory requirements.